K200963 is an FDA 510(k) clearance for the Halo Single-Loop Microsnare Kit. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).
Submitted by Argon Medical Devices, Inc. (Athens, US). The FDA issued a Cleared decision on January 5, 2021, 270 days after receiving the submission on April 10, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K200963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2020 |
| Decision Date | January 05, 2021 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MMX — Device, Percutaneous Retrieval |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |